An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections
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|ClinicalTrials.gov Identifier: NCT01823289|
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Fungal Infection||Drug: Itraconazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Efficacy and Safety of Itraconazole Injection/Oral Solution Sequential Therapy for Treatment of Invasive Pulmonary Fungal Infections|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||January 2009|
|Experimental: Itraconazole Sequential Therapy||
Itraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks.
- Number of Participants With Clinical Efficacy [ Time Frame: Week 6 ]Clinical efficacy was assessed as cured: the signs and symptoms of invasive fungal infections (IFI) completely disappeared or full or nearby resolution of radiographic manifestations; markedly improved: the signs and symptoms of IFI were improved or disappeared and at least 50 percent improvement of radiographic findings; improved: the signs and symptoms of IFI were moderately improved and less than 50 percent improvement of radiographic findings; failed: the clinical symptoms and signs of IFI were not changed or worsened.
- Number of Participants With Mycological Efficacy [ Time Frame: Week 6 ]Mycological efficacy was assessed as fungi cleared: negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); fungi not cleared: positive for fungal microscopic examinations and/or culture.
- Number of Participants With Comprehensive Efficacy [ Time Frame: Week 6 ]Comprehensive efficacy was assessed as cured: the symptoms, signs, laboratory examination and pathogenic examination were return to normal; markedly improved: the disease condition was markedly improved but symptoms, signs, laboratory examination and pathogenic examination were not return to normal; improved: the disease condition was improved to some extent after drug administration, but the improvement was not significant enough; failed: the disease condition was not improved significantly or worsened after drug administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823289
|Study Director:||Xian-Janssen Pharmaceutical Ltd., China Clinical trial||Xian-Janssen Pharmaceutical Ltd.|